LUND, Sweden, Oct. 27, 2020 /PRNewswire/ -- Immunovia, a
diagnostic company that develops highly accurate blood tests for
the early detection of cancer and autoimmune diseases, today
announced a necessary clarification to supplement the information
shared on 26 October 2020 (link to
press release).
About Blood Sample Inclusion Criteria
It is standard practice to have specific inclusion criteria in
place for the collection of blood samples for all diagnostic
studies. Immunovia has always implemented this Quality Control
process of samples and has worked very closely with the clinicians
to create the criteria for the Verification and Validation studies.
Samples that meet the quality requirements stipulated by the
inclusion criteria are included in a study.
Inclusion criteria can be, for example, but not limited to (i)
patients must not be under specific treatment, (ii) patients must
not have been anesthetized in direct connection with the sampling,
(iii) samples are lacking certain clinical data, etc.
Immunovia's Verification Study Quality Control
Process
After the samples were received for the Verification study,
Immunovia implemented the company's inclusion criteria. During this
quality control process, which is normal for all studies, it was
evident that some samples that did not meet the inclusion criteria.
According to Standard Operating Procedure (SOP) for clinical
studies, these samples do not go further in the testing process.
These samples were then replaced with samples that were originally
designated for the Validation Study. This was done to meet the
required number of samples derived from the power calculation, the
calculation done to determine how many samples will be needed to
successfully complete the study.
It is important to note that the samples that do not fulfil the
inclusion criteria are not, so called, "outliers". Outliers are
identified after the test is performed, not during the inclusion QC
process, and must be handled with the utmost caution not to affect
the outcome in an incorrect way. This is also standard in all
clinical studies and no samples were treated as outliers in the
verification study.
The company's timeline was affected by the delay in the
completion of the sample collection for the Validation study due to
the fact that sampling at the collection centers has recently
significantly decreased due to COVID-19.
For more information, please contact:
Julie Silber, Director of
Investor Relations, Immunovia
Email: julie.silber@immunovia.com
Tel: +46 7 93 486 277
About Immunovia
Immunovia AB is a diagnostic company that is developing and
commercializing highly accurate blood tests for the early detection
of cancer and autoimmune diseases based on Immunovia's
proprietary test platform called IMMray™. Tests are based on
antibody biomarker microarray analysis using advanced
machine-learning and bioinformatics to single-out a set of relevant
biomarkers that indicate a certain disease. Thus, forming a unique
"disease biomarker signature".
The company was founded in 2007, based on cancer studies and
ground-breaking research in the Department of Immuntechnology at
Lund University and CREATE Health
Cancer Center, Sweden.
The first product, IMMray™ PanCan-d, is undergoing clinical
evaluation in some of the world's largest clinical studies for
pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1 and is
currently in the final validation phase. The company aims for a
sales start at the end of Q1 2021 with subsequent commercial
testing in Q2.
When validated, IMMray™ PanCan-d will be the first blood-based
test for early diagnosis of pancreatic cancer on the market, with a
potential to significantly improve patient survival and
outcome.
Immunovia Dx Laboratories located in Marlborough, Massachusetts, USA and
Lund, Sweden will provide
laboratory testing services in two accredited reference
laboratories.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For
more information, please visit www.immunovia.com.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/immunovia-ab/r/immunovia-provides-complementary-information-on-the-immray--pancan-d-verification-and-validation-stu,c3226370
The following files are available for download:
https://mb.cision.com/Main/13121/3226370/1326677.pdf
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SOURCE Immunovia AB